For the second time in five years, the Centers for Medicare & Medicaid Services (CMS) has proposed to erase the inpatient-onlylist over a span of three years, stating that physicians are capable of deciding which site of service is best for their patients.
The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.
Merit Medical Systems Inc. reported it is buying the lead management assets of Cook Medical Inc. for $210 million in cash. The Cook products consist of lead extraction devices and other lead management products.
Merit Medical Systems Inc. acquired the Esophyx Z+ device from Endogastric Solutions Inc. for $105 million in cash, adding a durable, non-pharmacological treatment for gastroesophageal reflux disease to its line-up of gastrointestinal products.
Merit Medical Systems Inc. is making progress on its acquisition badge, with a $100 million purchase of assets from Angiodynamics Inc. following shortly on the heels of its acquisition of a catheter system from Bluegrass Vascular Technologies Inc. for $32.5 million. The acquisitions strengthen Merit’s position in the specialty dialysis devices market and are expected to boost the company’s revenues $13 million to $15 million through Dec. 31, 2023, and by $30 million on an annualized basis going forward.
Merit Medical Systems Inc. received a U.S. FDA breakthrough device designation for its Scout MD surgical guidance system, which enables physicians to pinpoint tumor location in soft tissue. The system uses up tiny reflectors to provide multidimensional location data that can improve the ability to remove the entire tumor with minimal trauma to the surrounding tissue, which can be a challenge in surgeries such as lumpectomies.
Merit Medical Systems Inc. received FDA 510(k) clearance for the Scout Bx delivery system, which enables the placement during stereotactic and MRI-guided biopsy of a reflector to guide breast surgery. The delivery system works with the company’s Scout reflector, a wire-free radar localization device.
Molli Surgical Inc. has won the FDA’s nod for its wire-free localization technology for breast cancer surgery. The company said the Molli system helps radiologists tag cancerous lesions quickly and precisely, facilitating surgical excision and eliminating a source of anxiety associated with breast tumor removal.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Federal Circuit declines to overturn lower court ruling for Medtronic; FDA stands pat on biotin interference threshold in final guidance; CMS adds to telehealth list.